China NMPA Product Recall - electric wheelchair

Henan Hesen Medical Equipment Co., Ltd. has initiated a voluntary Level III recall for specific electric wheelchairs due to critical safety non-compliances. This action, overseen by the National Medical Products Administration (NMPA), was publicly announced on September 18, 2020, following the company's report dated September 12, 2020. The issue originated from a random inspection conducted by the Shaanxi Provincial Medical Device Quality Supervision and Inspection Institute, which identified product deficiencies.

The main violations pertain to the electric wheelchair model WC05904ZTL, specifically batch number 190816, manufactured in August 2019. These units failed to meet established requirements for both maximum speed and horizontal road braking, presenting potential safety hazards for disabled persons, patients, and the elderly. Three affected units were distributed and sold within China.

Required actions by Henan Hesen Medical Equipment Co., Ltd. include immediately notifying all users and distributors to cease the use and sale of the non-compliant products. The company must retrieve all affected units from the market, conduct thorough testing, and recalibrate parameters to align with standard specifications. Additionally, the company is mandated to investigate the root cause of these deficiencies, develop comprehensive corrective measures, and ensure their effective implementation to prevent future occurrences, upholding product safety under NMPA's regulatory guidance.